Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to OECD test guideline 423 under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
once a slighlty decreased environmental temperature
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): SULFANTLIC ACID TECHNICAL GRADE
- Physical state: grey powder
- Analytical purity: 99.12%
- Lot/batch No.: M001/09
- Expiration date of the lot/batch: 01.10.2011
- Storage condition of test material: dry at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage JANV1ER (53940 Le Genest St Isle — France)
- Age at study initiation: 8 weeks
- Weight at study initiation: 178 g to 197 g
- Housing: Healthy female rats were housed by group of three in solid-bottomed clear polycarbonate cages with a
stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a
week. Each cage was installed in conventional air conditioned animal husbandry.
- Diet (e.g. ad libitum): Food was removed at D-1 and then redistributed 4 hours after the test item administration
- Water (e.g. ad libitum): ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 -26 °C
- Humidity (%): 40 -58%
- Air changes (per hr): aprox. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distilled
Details on oral exposure:
The preparation was administered by gavage with a volume of 10 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
none
Body weight:
The body weight development of the animals remained normal throughout the study.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a study according to OECD test guideline 423 (acute oral toxicity) under GLP, the LD50 (rat) of the test substance was determined to be > 2000 mg/kg bw.
Executive summary:

The test substance was administered to a group of 6 female Sprague Dawley rats at the single dose of 300 mg/kg body weight and to a group of 6 female Sprague Dawley rats at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D, guideline N° 423 dated December 17th, 2001. No mortality occurred during the study at 300 mg/kg or at 2000 mg/kg body weight. No clinical signs related to the administration of the test substance were observed. The body weight development of the animals remained normal throughout the study. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. In conclusion, the LD50 of the test isubstance is higher than 2000 mg/kg body weight by oral route in the rat.